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CONTENTS HEALTH LAW NEWSLETTER I JUNE, 2017 I AMENDMENT TO REGULATION ON THE PRIOR EXPORT OF MEDICINAL PRODUCTS II TRANSPARENCY AND PROMOTION: SCIENTIFIC EVENTS AT NHS AND TRANSPARENCY PLATFORM III NATIONAL LEGISLATION

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HEALTH LAW NEWSLETTER

I AMENDMENT TO REGULATION ON THE PRIOR EXPORT OF MEDICINAL PRODUCTS

The new Regulation on the notification of transactions of medicinal products for other countries came into force on June 20, approved by Infarmed's Resolution 524/2017, of April 13.

The purpose of this deliberation is to update the Regulation on the prior export notification or distribution to other Member States and to update the list of medicinal products whose export or distribution to other Member States depends on prior notification to Infarmed.

The new wording of the Regulation materializes the criteria for the inclusion by Infarmed on the mentioned list of the medicinal products that require prior notification for their exportation. These evaluation criteria include: (i) relationship between the reports of difficulties in the access to the medicinal products and the quantities of these medicinal products placed on the domestic market by the MAH; (ii) relationship between the quantity of medicinal products exported and the quantity of medicinal products placed on the domestic market by the MAH; (iii) availability of alternative therapies; (iv) the active substance is considered critical; and (v) possibility of a rupture of supply in the domestic market by the MAH.

This amendment to the Regulation is essentially based on a recommendation of the European Commission addressed to Portugal due to the fact that it was to creating unjustified difficulties in the export of medicinal products by requiring wholesale distributors to notify in advance the medicinal products they intend to export on the basis of the risk of going out of stock.

Following the entry into force of Decree-Law 5/2017, of 6 January, which established new rules (and prohibitions) for the undertaking, at hospitals and services of the National Health Service ("NHS"), of scientific events and for the donations made by the pharmaceutical industry to these entities, the Government published Order 5657/2017, to clarify the scope of application of said legal diploma and to define the authorization process established therein.

Pursuant to the aforementioned order, and contrary to what was previously established, it is defined the authorization procedure that shall be submitted in order to carry out, at the NHS hospitals, scientific events sponsored by pharmaceutical and medical devices companies. For this to occur, it is necessary for the governing bodies of the NHS hospitals and services to submit an application for authorization through the Transparency Platform of Infarmed, according to which they declare that those scientific actions are not promotional. The request for authorization shall be submitted 60 days in advance of the date of the event and will be decided in 5 working days by Infarmed.

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Taking advantage of the amendments to the above mentioned Order, Infarmed also took this opportunity to update the Transparency Platform in what respects the notifications to be submitted by companies in the pharmaceutical sector and medical devices and the validation obligations from the entities receiving these benefits.

III NATIONAL LEGISLATION

Infarmed

Resolution of the Council of Ministers 69/2017 D.R. 107/2017, Series I of 2017-06-02 Presidency of the Council of Ministers

Appoints Maria do Cu Lourinho Soares Machado as President of the Board of Directors of INFARMED - National Authority for Medicines and Health Products, I.P.

Deliberation 459/2017 D.R. 107/2017, Series II of 2017-06-02

Appoints the Directorate of the Medicines Evaluation Committee to the new term, being appointed as President, Vasco Antnio de Jesus Maria.

Order 4841/2017 D.R. 107/2017, Series II of 2017-06-02

Subdelegation of powers of the Member of the Board of Directors of INFARMED in Marta Marcelino, Director of the Directorate of Evaluation of Medicines.

Vaccines

Order 139/2017 D.R. 107/2017, Series II of 2017-06-02 Finance and Health - Cabinets of the Secretaries of State for Budget and Health

Authorizes the Regional Health Administration of the North to assume a charge in 2017 up to the amount of 2,588,830.19 EUR for the acquisition of vaccines.

Resolution of the Parliament 123/2017 D.R. 117/2017, Series I of 2017-06-20 Parliament

Recommends that the Government adopt measures to comply with the National Vaccination Program.

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Hospital units

Resolution of the Council of Ministers 84/2017 D.R. 115/2017, Series I of 2017-06-16 Presidency of the Council of Ministers

Appoints Carlos Manuel Gregrio dos Santos and Maria do Rosrio Simes Rodrigues Velez Reis, respectively, to the positions of President and Executive Member of the Board of Directors of the Portuguese Institute of Oncology of Coimbra Francisco Gentil (IPO), E. P. E.

Resolution of the Council of Ministers 86/2017 D.R 116/2017, Series I of 2017-06-19 Presidency of the Council of Ministers

Resolution of the Parliament 125/2017 D.R. 117/2017, Series I of 2017-06-20 Parliament

Recommends that the Government review Order 287/2016 of 10 November, in order to ensure that the exceptional arrangements for 100% reimbursement of the price of medicines apply to retired workers in the wool industry, in particular those by 1984, to the Special Fund for Social Security of Wool Industry Personnel and future pensioners for all reimbursed medicines, without prejudice to the preference that should be given to generic medicines.

Order 193/2017 D.R. 117/2017, Series I of 2017-06-20

It determines the maximum prices for the acquisition of continuous subcutaneous insulin infusion devices (PSCI) and respective consumables for the entities supervised by the member of the Government responsible for health.

National Health Service

Order 207/2017 D.R. 132/2017, Series I of 2017-07-11

Approves the Regulations and the Tables of Prices of the Institutions and Services Integrated in the National Health Service, regulates the Integrated System of Management of Subscribers for Surgery, which becomes part of the Integrated System of Access Management, and defines the prices and conditions under which additional production may be remunerated.

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Family Health Units

Decree-Law 73/2017 D. R. 118/2017, Series I of 2017-06-21

Changes the legal regime of family health units.

Transport of patients

Order 94/2017 D.R. 118/2017, Series I of 2017-06-21

Sixth amendment to Administrative Rule 142-B / 2012, of May 15, defines the conditions under which the National Health Service assures the non-urgent costs of transportation of patients that is instrumental in the delivery of health care , in order to include the costs of this transport on patients in need of palliative care.

Gestation Replacement

Council of Ministers of 22 June 2017

The regulatory decree on the law regulating access to gestation replacement was approved. According to the communication of the Council, the approved law defines the prior authorization procedure that is subject to the conclusion of legal business of gestation replacement, as well as the gestation contract of substitution, whose supervision is the responsibility of the National Council for Medically Assisted Procreation, and the interests of the child shall prevail over any other, and the interests of the pregnant woman shall be taken into account.

National System for the Evaluation of Health Technologies (SiNATS) Council of Ministers of 22 June 2017

The amendment of the National Health Technology Assessment System (SiNATS) was approved, which clarifies some provisions to ensure the implementation of the objectives that led to its creation, with a view to the correct application of the mechanism of Exceptional Authorizations for the Use of Medicinal Products.

Donation

Order 5480/2017 D.R. 120/2017, Series II of 2017-06-23

Creates a working group to elaborate the normative matrix of the Hospital Rules on Donation that should be elaborated and adopted by all the hospitals with activity of donation and collection of organs and tissues.

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Conscientious Objection

Regulation 344/2017 D.R. 122/2017, Series II of 2017-06-27 Nurses' Order Regulation on the exercise of the right to object to conscientious objection.

National Health Council

Resolution of the Council of Ministers 89/2017 D.R. 123/2017, Series I of 2017Presidency of the Council of Ministers Designates Maria Isabel Guedes Loureiro as vice president of the National Health Council

European Medicines Agency

Resolution of the Council of Ministers 96/2017 D.R. 129/2017, Series I of 2017-07-06 Presidency of the Council of Ministers Amends the National Commission for the establishment of the European Medicines Agency to reformulate the establishment of the Agency in Portugal, in the cities of Lisbon or Porto.

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